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343 device results listed.

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Actim® Calprotectin

35032ETAC

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Actim Oy
Manufacturer SRN: FI-MF-000024323
UDI-DI: D-6430030990653UC
Basic UDI-DI: B-6430030990653UC
Reference: 35032ETAC
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Finland
Authorised representative: -
Last updated: 17.07.2026 03:43

Manufacturer products View details

Microalbumin Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M23C3Z5
Basic UDI-DI: B-5M23C3Z5
Reference: 5M23C3-25-EU, 5M23C3-50-EU
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1C Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M22C2YW
Basic UDI-DI: B-5M22C2YW
Reference: 5M22C2-25-EU, 5M22C2-50-EU
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C Test (FIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-5M15C2Z6
Basic UDI-DI: B-5M15C2Z6
Reference: 5M15C2-25-EU, 5M15C2-50-EU
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 17.07.2026 03:07

Manufacturer products Authorised representative products Authorised representative actors View details

STANDARD™ F HbA1c

F-A1C

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SD Biosensor Inc.
Manufacturer SRN: KR-MF-000009168
UDI-DI: 08800111725661
Basic UDI-DI: 88001117IPCA01FA05VX
Reference: 10A1C20B
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Italy
Safety summary (SSCP/SSP): SDB-SSP-TDC-FA05 · Rev. 03
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 16.07.2026 12:42

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

NADAL®PROM Amniotic fluid Test

PROM Amniotic fluid Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-431006N-10VG
Basic UDI-DI: B-nvm-431006N-10VG
Reference: 431006N-10
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

NADAL® Microalbumin Test

Microalbumin Test

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: nal von minden GmbH
Manufacturer SRN: DE-MF-000013321
UDI-DI: D-nvm-331901N-50XZ
Basic UDI-DI: B-nvm-331901N-50XZ
Reference: 331901N-50
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 15.07.2026 14:28

Manufacturer products View details

Micro-Albumin Qualitative Rapid Test

VNMB-101

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VNMB-101PN
Basic UDI-DI: B-VNMB-101PN
Reference: VNMB-101
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:24

Manufacturer products Authorised representative products Authorised representative actors View details

D-TRF-F233Z

Transferrin Rapid Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-TRF-F233Z
Basic UDI-DI: B-TRF-F233Z
Reference: /
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 11:00

Manufacturer products Authorised representative products Authorised representative actors View details

Cystatin C (GFR) test kit (32 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0240DB
Basic UDI-DI: B-ST0240DB
Reference: ST0240
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:34

Manufacturer products View details

Lipoprotein (a) test kit (16 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0141D8
Basic UDI-DI: B-ST0141D8
Reference: ST0141
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

HbA1c test kit (24 tests)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagent

Manufacturer: EUROLyser Diagnostica GmbH
Manufacturer SRN: AT-MF-000013746
UDI-DI: D-ST0110CV
Basic UDI-DI: B-ST0110CV
Reference: ST0110
EMDN: W0102160102
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT & POC
First on market country: Austria
Authorised representative: -
Last updated: 15.07.2026 10:32

Manufacturer products View details

D-NormalFerritinVP

Normal Ferritin

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-NormalFerritinVP
Basic UDI-DI: B-NormalFerritinVP
Reference: /
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:08

Manufacturer products Authorised representative products Authorised representative actors View details

D-MT-F42001UK

Transferrin and Fecal Occult Blood Combo Test

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-MT-F42001UK
Basic UDI-DI: B-MT-F42001UK
Reference: /
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 05:16

Manufacturer products Authorised representative products Authorised representative actors View details

MAU Test Kit FIA

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAU-A06aEY
Basic UDI-DI: B-MAU-A06aEY
Reference: MAU-A06a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Netherlands
Authorised representative: SUNGO Europe B.V.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

MAU Rapid Test

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-MAU-A02aEL
Basic UDI-DI: B-MAU-A02aEL
Reference: MAU-A02a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 04:53

Manufacturer products Authorised representative products Authorised representative actors View details

D-HighFerritinWW

High Level Ferritin

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: D-HighFerritinWW
Basic UDI-DI: B-HighFerritinWW
Reference: /
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 01:00

Manufacturer products Authorised representative products Authorised representative actors View details

Calprotectin / Lactoferrin Rapid Test Kit (Intestinal Inflammation)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD130X7
Basic UDI-DI: B-GKPD130X7
Reference: GKPD130
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Midstream (Urine)

GIHSA-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GIHSA-103aHG3T
Basic UDI-DI: B-GIHSA-103aHG3T
Reference: GIHSA-103a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

One Step Microalbumin Test Cassette (Urine)

GIHSA-103a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GIHSA-103a4D
Basic UDI-DI: B-GIHSA-103a4D
Reference: GIHSA-103a
EMDN: W0102160101
EMDN description: ALBUMIN INCL. UALBUMIN RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details